QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as QuidelOrtho, we are seeking Senior Quality Engineer/ Quality Inspector. The Supplier Quality Engineer / Senior Quality Inspector will provide quality engineering and incoming material inspection support at the Rochester Site. The candidate will develop and maintain effective working relationships with suppliers and manage material quality acceptance activities, part qualification processes, supplier-related nonconformance's and maintain incoming inspection records. The candidate will utilize inspection measurement tools, sampling methodologies, and design specifications to establish and maintain material acceptance criteria for new and existing items purchased from external sources. The candidate will maintain up-to-date quality inspection status in SAP through coordination with the cross-functional team reviews of material quality records. The candidate will utilize key Quality Engineering principles, tools, and practices to develop and optimize process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and QuidelOrtho' s Quality Policy. The candidate will also utilize risk management and process excellence tools to identify risk factors in the quality system and lead activities to implement risk mitigation plans. The candidate will have familiarity with documentation and change management systems to provide documentation updates as needed, compile and present quality metrics to leadership.

This position is located in Rochester, NY.

• Support manufacturing and staff in addressing supplier-related quality events for raw materials by working with suppliers to drive the identification of root cause and implementation of corrections and corrective actions while adhering to quality metric timelines.

• Work with engineering, product support, and quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of and changes to inspection methods and sampling plans for materials and components.

• Ensure adequate supplier control plans are implemented, documented, and maintained.

• Develop quality agreements, oversee supplier monitoring activities, and support supplier changes.

• Partner with operations to evaluate and address quality events including nonconformance's, product dispositions, root cause investigations, and implement appropriate CAPA based on risk level.

• Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.

• Support and promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce variation and improve product quality.

• Provide coaching, training, and technical guidance to business partners in aspects of the company quality system requirements as they pertain to manufacturing quality and provide guidance of effectively applying key quality engineering principles and tools.

• Support and participate in inspection readiness activities of respective area by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.

• Work to resolve supplier nonconformance's by ensuring adequate RCIs are conducted and effective CAPAs are implemented.

• Perform other work-related duties as assigned.

Required Skills:

• Bachelor Degree in Chemistry, Biochemistry, Biology, Engineering, or equivalent experience.

• 5 years of experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).

• Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis.

• Working knowledge of good manufacturing practices per FDA and ISO requirements and/or regulations.

• Required Travel: Less than 10% domestic and/or international.

• Perform other work-related duties as assigned.

Internal Partners: Partner with Operations, Engineering, Product Support, Laboratory Personnel, Regulatory Affairs, and Compliance

External Partners: Regulatory Agencies and Suppliers

The work environment characteristics are representative of a manufacturing and laboratory, environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 50% of time in meetings, working with team; 50% of the time at the desk on computer, walking, standing, or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.Flexible work hours to meet project deadlines.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at

#LI-SP1